Guidance for industry on providing
regulatory information in electronic
format: Non-eCTD electronic
submissions (NeeS) for human medicinal
products
Version: 1.0
December 2010
Document change record
1
Details of Change
Section
Date
First version
All
December 2010
Table of contents
1
Introduction ................................................................................................................. 5
2
General considerations ................................................................................................ 5
2.1 – Scope ...................................................................................................................... 5
2.1.1. Type of product ................................................................................................. 5
2.1.2. Type of submission ........................................................................................... 5
2.2 – Structure of submissions ........................................................................................ 5
2.2.1. Table of contents and bookmarks ..................................................................... 6
2.3 – Submission numbering........................................................................................... 7
2.4 – Moving to NeeS format applications ..................................................................... 7
2.5 – General submission considerations ........................................................................ 7
2.5.1. File and folder structure .................................................................................... 7
2.5.2. File naming ....................................................................................................... 7
2.5.3. Placement of documents ................................................................................... 7
2.6 – Correspondence...................................................................................................... 7
2.7 – Paper requirements................................................................................................. 8
2.8 – Hardware ................................................................................................................ 8
2.9 – File formats ............................................................................................................ 8
2.9.1. PDF ................................................................................................................... 8
2.9.2. Extensible mark-up language (XML) ............................................................... 8
2.9.3. Other file formats .............................................................................................. 8
2.10 – Bookmarks and hypertext links ........................................................................... 9
2.11 – Other technical information ................................................................................. 9
2.11.1. Security issues ................................................................................................. 9
2.11.2. Password protection ........................................................................................ 9
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2.11.3. Virus protection .............................................................................................. 9
2.11.4. Electronic signatures ....................................................................................... 9
2.11.5. Transmission media ........................................................................................ 9
2.11.6. Labelling of media ........................................................................................ 10
2.11.7. Procedure for sending electronic information............................................... 10
2.12.8. Archiving and working copies ...................................................................... 10
3
Module specific information ..................................................................................... 10
3.1 – Module 1.2: Administrative information (application forms) ............................. 10
3.2 – Module 1.3.1: Product information ...................................................................... 11
3.3 – Module 1 – responses........................................................................................... 11
Annex 1
Guidance on text searchable documents ........................................................ 12
1 – General .................................................................................................................... 12
1.1. Creating text searchable files ............................................................................. 12
2 – Documents that must always be text searchable ..................................................... 12
3 – Documents that do not need to be text searchable .................................................. 13
4 – Further information ................................................................................................. 14
Annex 2
Example tables of contents ............................................................................ 15
Annex 3
Naming of files .............................................................................................. 25
Electronic format guidance: NeeS
December 2010
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1
Introduction
This Guidance Document is intended to assist pharmaceutical companies with the
submission of regulatory information in electronic format to the Therapeutic Goods
Administration (TGA). This document details the requirements for the submission of
non-eCTD electronic submissions (NeeS). A separate guidance document covering eCTD
submissions is also being published on the TGA website.
It should be stressed that this document reflects the current situation and will be regularly
updated in the light of changes in legislation together with further experience gained
using information submitted in electronic format. NeeS applications should be regarded
as an interim format and that applicants should be actively planning their move to full
eCTD submissions.
2
General considerations
2.1 – Scope
2.1.1. Type of product
The product types include small molecules, vaccines, and blood products for human
medicinal products described in Part 1 of Schedule 10 of the Therapeutic Goods
Regulations 1990.
2.1.2. Type of submission
This guidance applies to all submissions related to the authorisation and maintenance of
medicinal products, including new registrations, variations, PSURs and active substance
master files.
2.2 – Structure of submissions
Regulatory information must be structured in accordance with the common technical
document (CTD), which for paper submissions became mandatory in the Australia with
effect from February 2006.
For NeeS applications the eCTD folder structure is used. The breakdown of the electronic
submission should be in conformity with the ICH granularity document and the ICH
eCTD file naming conventions and recommended TGA file names (see Annex 3).
The difference from an eCTD is that the two relevant XML files, the index.xml and auregional.xml for the backbone of modules 2 to 5 and module 1 for Australia, respectively
and the util folder are not present, so navigation through a NeeS is based on electronic
tables of content, bookmarks and hypertext links.
Typically, a NeeS application will cover all dosage forms and strengths of a product with
any one invented name. However, if the applicant decides to have one NeeS per strength
or dosage form, this would also be acceptable but should be carefully considered in
relation to transformation into eCTD at a later stage.
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2.2.1. Table of contents and bookmarks
Tables of content should still always be provided by the applicant. The TOCs should
always be submitted in PDF format.
All documents in the NeeS dossier should be referenced from a hyperlinked table of
contents (TOC). Hyperlinks for each document should always be provided to the first
page of the appropriate file.
In the case of small dossiers (e.g. for certain variations), especially when only one
module beside module 1 is concerned, it is acceptable to include only a main TOC
referring directly to the content documents. However, for larger submissions, the main
TOC should always be linked to module TOCs which are then further linked to the
documents in each module. The module TOCs should not include hyperlinks to
documents in other modules.
The file containing the main table of contents for the CTD should be named ctd-toc.pdf
and be located in the top level folder for the NeeS submission. The files containing the
module tables of content should be named m1-toc.pdf, m2-toc.pdf, m3-toc.pdf, m4-toc.pdf
and m5-toc.pdf and be located in the corresponding top level module folder.
An example is presented in Annex 2. It should be noted that these are just examples and
are provided for guidance and illustrative purposes only.
Where document TOCs are included they should be located within the same file as the
rest of the document. For each document, provide bookmarks for every entry in the
document's table of contents to the appropriate location, or where a table of contents does
not exist, provide bookmarks to a sufficiently detailed level, typically to Level 3 or 4
headings, as considered appropriate.
An additional function might be provided to allow easy navigation back to the Table of
Contents above. This can be achieved through the use of a bookmark linked back to the
previous level. This additional function is not mandatory, but when provided it will
facilitate the assessment.
The figure below describes diagrammatically this situation.
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2.3 – Submission numbering
Sequence numbers, as they are defined for eCTD submissions, are not applicable for
NeeS submissions.
The use of a four digit number in the top level folder name is however recommended.
The number does not have to be unique.
2.4 – Moving to NeeS format applications
A NeeS format application can normally be started with any application for initial
registration or variation of registration. Once the switch to this electronic format is made
it is expected that further applications and responses relating to the particular medicinal
product are submitted in the same electronic format.
Since there is no life cycle management for NeeS, there is no need to reformat the whole
dossier into NeeS format when switching from paper to NeeS.
2.5 – General submission considerations
2.5.1. File and folder structure
Submissions are a collection of documents and each document should be provided as a
separate file. The detailed structure of the NeeS should conform to the ICH granularity
document and Australian M1 guidance. It is recommended that the root folder of the
submission is named with the product (trade) name in lower case followed by the
subfolder, name, e.g. mydrug/0000/.
Total folder/file path should not exceed 180 characters.
2.5.2. File naming
The eCTD file naming conventions described in the ICH M2 eCTD specification and
Australian M1 guidance (see Annex 3) should be followed. If an applicant wishes to
submit multiple files in one section, where only one highly recommended name is
available, this can be achieved using a suffix to the filename, using the file name-var.pdf
convention, where the -var component has no dashes or illegal characters.
2.5.3. Placement of documents
Guidance on the placement of documents within the CTD structure for particular
submission types can be found on the TGA website.
(www.tga.gov.au/docs/html/eugctd.htm)
2.6 – Correspondence
In addition to the NeeS application, information may need to be exchanged to assist the
processing or handling of the application. Not all such correspondence need to be
included in the NeeS dossier.
Accordingly, the correspondence sent via the usual electronic means (email etc) only
needs to be in full NeeS format if it relates directly to the content of the dossier.
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2.7 – Paper requirements
The practical guidance for the paper submission of regulatory information in support of a
registration or variation application when using the electronic common technical
document (“eCTD”) as the source submission applies to NeeS submissions as well.
2.8 – Hardware
The TGA will not accept any hardware (laptops, desktops, zip drives, etc.) from sponsors
in connection with the submission of information in electronic format. The electronic
information should be directly readable and usable on the TGA’s hardware and software.
2.9 – File formats
Detailed guidance on the specific file formats can be found in the ICH eCTD
specification document.
2.9.1. PDF
In general terms the majority of documents included in electronic submissions should be
in PDF format.
Portable document format (PDF) is an open, de facto, electronic publishing standard,
created by Adobe Systems Incorporated. There are several alternative suppliers of PDF
software. Applicants need to check that the PDF documents meet the following key
requirements:

files should be legible with Acrobat Reader, version 5.0 or higher

PDF file version 1.4 only should be used

documents should be generated from electronic source documents and not from
scanned material, except where access to the source electronic file is unavailable
or where a signature is required. See Annex 1 for further guidance on text
searchable documents.
2.9.2. Extensible mark-up language (XML)
Extensible mark-up language (XML) is the format for the backbone files for the eCTD
but not in a NeeS dossier. Details on XML can be found in the ICH eCTD specification
document, Appendix 7.
2.9.3. Other file formats
Other file formats such as rich text (RTF) or MS Word formats may be required in
addition to the PDF requirement of the NeeS, especially for the provision of product
information documents.
These files should not be added within the NeeS structure. They should be provided in a
separate folder called, for example, ‘workingdocuments’ on the same CD/DVD
containing the NeeS.
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2.10 – Bookmarks and hypertext links
Navigation through an electronic submission is greatly enhanced by the intelligent use of
bookmarks and hypertext links. ICH guidance states: ‘It is expected that any document
that has a table of contents (TOC) will have bookmarks’ (see the eCTD specification for
details). Documents without TOCs should have bookmarks included where it aids in the
navigation around the document content. For example, a four page document
summarising findings could require bookmarks to aid navigation. However, a 300 page
file containing a single data listing might not require bookmarks as there is no further
internal structure.
In general terms, bookmarks and hyperlinks should be used to aid navigation.
Additional details on creating bookmarks and hypertext links in PDF documents can be
found in the ICH eCTD specification, Appendix 7.
Each document should be referred to from a table of content (the overall TOC or any
module TOC as applicable).
2.11 – Other technical information
2.11.1. Security issues
The physical security of the submission during transportation is the responsibility of the
applicant. Once received by the TGA, security and submission integrity is the sole
responsibility of the TGA.
2.11.2. Password protection
Submission or file level security is not permitted. If one-time security settings or
password protection of an electronic submission is used this could constitute grounds for
the rejection of the submission.
2.11.3. Virus protection
The applicant is responsible for checking the submission for viruses. Checking should be
performed with an up-to-date virus checker and be confirmed in the cover letter. After
receipt at the TGA, a similar internal virus check will be performed. If a virus is detected
it will constitute grounds for rejection of the submission.
2.11.4. Electronic signatures
The TGA requires that certain specific electronic documents (cover page for submission)
are authenticated by separate signed paper copies.
2.11.5. Transmission media
Currently CD-ROM, CD-R, DVD-R are considered acceptable media standards (USB
keys, hard drives etc are not acceptable). Sponsors should provide the electronic
information on the smallest number of discs possible, taking into consideration the size of
the submission.
If an individual NeeS submission is of such a size as to span several CDs, the provision
of a DVD is recommended. However, if the sponsor is unable to provide a DVD, and the
application spans multiple CDs, then, where possible, individual CTD modules should be
Electronic format guidance: NeeS
December 2010
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kept together and not be split over multiple CDs (i.e. a single CD should contain all of
module 1, another all of module 2, etc.).
A separate CD/DVD should be provided for each NeeS submission. When submitting
several applications for the same medicinal product (trade name) concurrently, it would
be acceptable to provide them on a single CD/DVD.
This should always be clearly described in the cover letter and indicated on the disc (see
2.11.6).
2.11.6. Labelling of media
Each CD or DVD submitted with a NeeS should include the following label information,
clearly presented and printed on the media:

format: NeeS

applicant’s name

product (trade) name(s)

AAN of the active substance(s)

full submission number(s)

number of media units per full set and an indication of the place of the individual
CD/DVD within this set (e.g. 1(5), 2(5), etc.)

submission type(s) of each NeeS submission(s) contained on the CD/DVD (e.g.
new chemical entity, extension of indications).
2.11.7. Procedure for sending electronic information
Electronic media sets should be submitted at the same time as any required paper
documentation. The electronic media should be packed adequately to prevent damage and
the package should include a cover letter.
2.12.8. Archiving and working copies
Six copies of the full electronic dossier must be provided for category 1 and category 2
submissions.
3
Module specific information
3.1 – Module 1.2: Administrative information (application forms)
The application form should always be provided as a PDF file within the NeeS structure
and provided as a signed paper copy. For this specific PDF file a newer version than PDF
version 1.4 may be appropriate and acceptable.
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3.2 – Module 1.3.1: Product information
For NeeS applications, product information should be supplied as PDF files within the
NeeS structure. For products already registered and changes to the product information
are proposed, submission dossier must include both the ‘annotated’ Australian PI and a
‘clean’ Australian PI. A ‘clean’ Australian PI incorporates all the changes proposed but
removes the revision marks and comments.
An MS Word file version should also be submitted to facilitate assessment. These files
should not be added within the NeeS structure. They should be provided in a separate
folder called, for example, ‘workingdocuments’ on the same CD/DVD containing the
NeeS (see also section 2.9.3).
3.3 – Module 1 – responses
The organisation of the submission of electronic information in response to a list of
questions from the TGA should follow the same basic principles as the first submission.
The written response should be submitted following the recommended response folder
and file structure. In this case the written response document should be placed in a folder
named for example mydrug/0000/m1-0-2-responses-quest. Appropriate navigation in the
submission should follow the same concepts as described in section 2.2.1.
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Annex 1 Guidance on text searchable documents
1 – General
Sponsors are requested to ensure that all submissions contain the maximum amount of
text searchable content. Documents with searchable text will aid the evaluator, or any
other user, in searching for specific terms and also in copying and pasting information
into another document, such as an evaluation report.
This short document provides some guidance about what must be text searchable and the
ways to ensure that files are created appropriately.
1.1. Creating text searchable files
Portable document files (PDFs) with searchable text can be created by all PDF tools from
a source file in a text format (e.g. MS Word, SAS, MS PowerPoint, Rich Text Files, etc.).
When created in this way, the file will usually be the smallest in size (measured in
kilobytes or megabytes) that they can be.
If the only version of a document available is in paper, then scanning to PDF and using
an optical character recognition (OCR) routine is the only way to create searchable text.
PDF files created in this way tend to be much larger in size, for the same number of
pages (from 10 to 100 times as large), and the quality of the text that is created will
almost certainly not be a 100% match to the original text. It is noted that tools for
checking and correcting this text tend to be somewhat cumbersome. For these reasons,
applicants are recommended to use scanning/OCR only as a last resort.
Applicants are reminded that the text produced by the OCR routine should be ‘hidden’
behind the image of the original page so that the user can refer to the picture of the page
and the text on it as final verification of the data. As a result, the applicant should ensure
that, as a minimum, the text on the scanned image is legible to the user. Poor quality
images should not be provided and you should note that these can only inevitably lead to
poor quality OCR text.
2 – Documents that must always be text searchable
Text searchable means the PDF should be produced wherever possible from a text source,
such as MS Word, but if soured from a scanned original then it must be OCR format.
The following must always be text searchable:

key administrative documents in module 1 including, the cover letter, application
form, product information documents

any document in module 2 of the submission (QOS, non-clinical overview and
summaries, clinical overview and summaries)

the main body of text and main tables in any non-clinical or clinical report
required to support the main claim of the submission
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
the main body of text in any reports, methods, analytical procedures, etc. supplied
in module 3 of the submission

the main body of text of periodic safety update reports (PSURs)

the main body of text of risk management plans

any English translation of a document originally written in a foreign language (see
also below).
3 – Documents that do not need to be text searchable
The PDF of documents from this category should be produced wherever possible from a
text source, such as MS Word, but if sourced from a scanned original then there is no
need for OCR format.
Documents in this category are:

any original GMP certificate

any original certificate of analysis

any manufacturer’s licences

any certificates of suitability

any manufacturing authorisation

any document written in a foreign language where a translation is provided in
English (however, the translation should be text searchable, see above)

any literature references sourced from journals, periodicals and books (except
when these are used in a bibliographic application to support the main claims of
the application)

the blank case report form in a clinical study report

patient data listings (when supplied)

case report forms (when supplied)

any page with a signature that does not contain other information key to the
understanding of the submission
o applicants should consider providing signatures on separate pages from
key text in reports, overviews, etc.
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4 – Further information
If applicants are uncertain whether or not a particular document should be text
searchable, they should contact the TGA for guidance.
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December 2010
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Annex 2
Example tables of contents
These tables of contents are examples and are provided for illustrative and guidance
purposes only. The blue underlined text illustrates where hyperlinks to the individual
documents may be added.
In these examples there are some “Not applicable” documents shown. “Not applicable”
documents should not appear in the dossier and nor should they be included in the TOCs.
The following is an example of a CTD TOC (main TOC)
Module 1
Module 2
Module 3
Module 4
Module 5
Administrative information and prescribing information for
Australia
Common technical document summaries
Quality
Non-clinical study reports
Clinical study reports
Module 1
Module 2
Module 3
Module 4
Module 5
The following are examples of module TOCs.
Module 1
1.0
1.0.0
1.0.1
1.0.2
1.1
1.2
1.2.1
1.2.2
1.2.3
1.3
1.3.1
1.3.2
1.3.3
1.3.4
1.4
1.4.1
1.4.2
1.4.3
1.5
1.5.1
1.5.2
1.5.3
1.5.4
1.5.5
1.6
1.6.1
Administrative information and prescribing information
for Australia
Letter of application
Electronic lodgement cover sheet
Letter of application
Responses to questions
Comprehensive table of contents
Application forms
Application form
Pre-submission details
Patent certification
Medicine information documents, packaging, and labelling
Proposed Australian product information and package insert
Proposed Australian consumer medicine information
Therapeutic goods and use of human embryos or human
embryonic stem cells or material derived from them
Label mock-ups and specimens
Information about the experts
Information about the expert – Quality
Information about the expert – Non-clinical
Information about the expert – Clinical
Specific requirements for different types of applications
Literature based submission documents
Orphan drug designation
Genetically modified organisms: Consent from the Office of the
Gene Technology Regulator
Additional trade name declarations
Co-marketed medicine declarations
Drug and plasma master files and Certificates of Suitability of
Monographs of the European Pharmacopoeia
Relevant external sources
Electronic format guidance: NeeS
December 2010
1.0
1.0.0
1.0.1
1.0.2
1.1
1.2
1.2.1
1.2.2
1.2.3
1.3
1.3.1
1.3.2
1.3.3
1.3.4
1.4
1.4.1
1.4.2
1.4.3
1.5
1.5.1
1.5.2
1.5.3
1.5.4
1.5.5
1.6
1.6.1
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1.10.3
1.11
1.11.1
1.11.2
1.12
1.12.1
1.13
1.13.1
Annex I
Annex II
Administrative information and prescribing information
for Australia
Sponsor’s declaration
Letters of access
Certificates of suitability (including Annexes)
Good manufacturing practice
List of Australian manufacturer names and licence numbers
GMP clearance letters for all overseas manufacturing sites
Copies of applications for TGA GMP clearances
Compliance with meetings and pre-submission processes
Details of compliance with pre-submission meeting outcomes
Details of any additional data to be submitted
Declaration of compliance with pre-submission planning form and
planning letter
Individual patient data
Individual patient data
Overseas regulatory status
Overseas regulatory status
Product information from Canada, the Netherlands, New Zealand,
Sweden, UK and USA
Data set similarities and differences
Summary of biopharmaceutic studies
Summary of a bioavailability or bioequivalence study
Justification for not providing appropriate biopharmaceutic studies
Paediatric development program
References to paediatric development program
Information relating to pharmacovigilance
Risk management plan for Australia
Antibiotic resistance data
Overseas evaluation reports
Module 2
2.2
2.3.S
2.3.S.1
2.3.S.2
2.3.S.3
2.3.S.4
2.3.S.5
2.3.S.6
2.3.S.7
2.3.S
2.3.S.1
2.3.S.2
2.3.S.3
2.3.S.4
2.3.S.5
2.3.S.6
2.3.S.7
2.3.P
2.3.P.1
2.3.P.2
2.3.P.3
2.3.P.4
2.3.P.5
Common technical document summaries
Introduction
Drug substance – Substance-R Maleate – Manufacturer
General information
Manufacture
Characterisation
Control of drug substance
Reference standards or materials
Container closure system
Stability
Drug substance - Substance-S – Manufacturer
General information
Manufacture
Characterisation
Control of drug substance
Reference standards or materials
Container closure system
Stability
Drug product - Efpiate capsule - Manufacturer3
Description and composition of the drug product
Pharmaceutical development
Manufacture
Control of excipients
Control of drug product
Module 1
1.6.2
1.6.3
1.6.4
1.7
1.7.1
1.7.2
1.7.3
1.8
1.8.1
1.8.2
1.8.3
1.9
1.9.1
1.10
1.10.1
1.10.2
Electronic format guidance: NeeS
December 2010
1.6.2
1.6.3
1.6.4
1.7
1.7.1
1.7.2
1.7.3
1.8
1.8.1
1.8.2
1.8.3
1.9
1.9.1
1.10
1.10.1
1.10.2
1.10.3
1.11
1.11.1
1.11.2
1.12
1.12.1
1.13
1.13.1
Annex I
Annex II
2.2
2.3.S
2.3.S.1
2.3.S.2
2.3.S.3
2.3.S.4
2.3.S.5
2.3.S.6
2.3.S.7
2.3.S
2.3.S.1
2.3.S.2
2.3.S.3
2.3.S.4
2.3.S.5
2.3.S.6
2.3.S.7
2.3.P
2.3.P.1
2.3.P.2
2.3.P.3
2.3.P.4
2.3.P.5
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Module 2
2.3.P.6
2.3.P.7
2.3.P.8
2.3.A
2.3.A.1
2.3.A.2
2.3.A.2
2.3.A.3
2.3.R
2.4
2.5
2.6
2.6.1
2.6.2
2.6.3
2.6.4
2.6.5
2.6.6
2.6.7
2.7
2.7.1
2.7.2
2.7.3
2.7.4
2.7.5
2.7.6
Module 3
3.2
3.2.S
3.2.S.1
3.2.S.1.1
3.2.S.1.2
3.2.S.1.3
3.2.S.2
3.2.S.2.1
3.2.S.2.2
3.2.S.2.3
3.2.S.2.4
3.2.S.2.5
3.2.S.2.6
3.2.S.3
3.2.S.3.1
3.2.S.3.2
3.2.S.4
3.2.S.4.1
3.2.S.4.2
3.2.S.4.3
Common technical document summaries
Reference standards or materials
Container closure system
Stability
Appendices
Facilities and equipment
Adventitious agents safety evaluation - Substance-S –
Manufacturer
Adventitious Agents Safety Evaluation - Substance-R Maleate
– Manufacturer
Novel excipients
Regional information
Nonclinical overview
Clinical overview
Nonclinical written and tabulated summary
Introduction
Pharmacology written summary
Pharmacology tabulated summary
Pharmacokinetics written summary
Pharmacokinetics tabulated summary
Toxicology written summary
Toxicology tabulated summary
Clinical summary
Summary of biopharmaceutic studies and associated
analytical methods
Summary of clinical pharmacology studies
Summary of clinical efficacy
Summary of clinical safety
Literature references
Synopses of individual studies
Quality
Body of data
Drug substance (substance-manufacturer)
General information (substance-manufacturer)
Nomenclature (substance-manufacturer)
Structure (substance-manufacturer)
General properties (substance-manufacturer)
Manufacture (substance-manufacturer)
Manufacturer(s) (substance-manufacturer)
Description of manufacturing process and process controls
(substance-manufacturer)
Control of materials (substance-manufacturer)
Control of critical steps and intermediates (substancemanufacturer)
Process validation and/or evaluation (substancemanufacturer)
Manufacturing process development (substancemanufacturer)
Characterisation (substance-manufacturer)
Elucidation of structure and other characteristics (substancemanufacturer)
Impurities (substance-manufacturer)
Control of drug substance (substance-manufacturer)
Specification (substance-manufacturer)
Analytical procedures (substance-manufacturer)
Validation of analytical procedures (substance-manufacturer)
Electronic format guidance: NeeS
December 2010
2.3.P.6
2.3.P.7
2.3.P.8
2.3.A
2.3.A.1
2.3.A.2
2.3.A.2
2.3.A.3
2.3.R
2.4
2.5
2.6
2.6.1
2.6.2
2.6.3
2.6.4
2.6.5
2.6.6
2.6.7
2.7
2.7.1
2.7.2
2.7.3
2.7.4
2.7.5
2.7.6
3.2
3.2.S
3.2.S.1
3.2.S.1.1
3.2.S.1.2
3.2.S.1.3
3.2.S.2
3.2.S.2.1
3.2.S.2.2
3.2.S.2.3
3.2.S.2.4
3.2.S.2.5
3.2.S.2.6
3.2.S.3
3.2.S.3.1
3.2.S.3.2
3.2.S.4
3.2.S.4.1
3.2.S.4.2
3.2.S.4.3
Page 17 of 33
Module 3
3.2.S.4.4
3.2.S.4.5
3.2.S.5
3.2.S.6
3.2.S.7
3.2.S.7.1
3.2.S.7.2
3.2.S.7.3
3.2.S
3.2.S.1
3.2.S.1.1
3.2.S.1.2
3.2.S.1.3
3.2.S.2
3.2.S.2.1
3.2.S.2.2
3.2.S.2.3
3.2.S.2.4
3.2.S.2.5
3.2.S.2.6
3.2.S.3
3.2.S.3.1
3.2.S.3.2
3.2.S.4
3.2.S.4.1
3.2.S.4.2
3.2.S.4.3
3.2.S.4.4
3.2.S.4.5
3.2.S.5
3.2.S.6
3.2.S.7
3.2.S.7.1
3.2.S.7.2
3.2.S.7.3
3.2.P
3.2.P.1
3.2.P.2
3.2.P.2.1
3.2.P.2.2
3.2.P.2.3
3.2.P.2.4
3.2.P.2.5
3.2.P.2.6
3.2.P.3
3.2.P.3.1
3.2.P.3.2
3.2.P.3.3
3.2.P.3.4
3.2.P.3.5
Quality
Batch analyses (substance-manufacturer)
Justification of specification (substance-manufacturer)
Reference standards or materials (substance-manufacturer)
Container closure system (substance-manufacturer)
Stability (substance-manufacturer)
Stability summary and conclusions (substance-manufacturer)
Post-approval stability protocol and stability commitment
(substance-manufacturer)
Stability data (substance-manufacturer)
Drug substance (substance-manufacturer1)
General information (substance-manufacturer1)
Nomenclature (substance-manufacturer1)
Structure (substance-manufacturer1)
General properties (substance-manufacturer1)
Manufacture (substance-manufacturer1)
Manufacturer(s) (substance-manufacturer1)
Description of manufacturing process and process controls
(substance-manufacturer1)
Control of materials (substance-manufacturer1)
Control of critical steps and intermediates (substancemanufacturer1)
Process validation and/or evaluation (substancemanufacturer1)
Manufacturing process development (substancemanufacturer1)
Characterisation (substance-manufacturer1)
Elucidation of structure and other characteristics (substancemanufacturer1)
Impurities (substance-manufacturer1)
Control of drug substance (substance-manufacturer1)
Specification (substance-manufacturer1)
Analytical procedures (substance-manufacturer1)
Validation of analytical procedures (substance-manufacturer1)
Batch analyses (substance-manufacturer1)
Justification of specification (substance-manufacturer1)
Reference standards or materials (substance-manufacturer1)
Container closure system (substance-manufacturer1)
Stability (substance-manufacturer1)
Stability summary and conclusions (substance-manufacturer1)
Post-approval stability protocol and stability commitment
(substance-manufacturer1)
Stability data (substance-manufacturer1)
Drug product
Description and composition of the drug product
Pharmaceutical development
Components of the drug product
Drug product
Manufacturing process development
Container closure system
Microbiological attributes
Compatibility
Manufacture
Manufacturer(s)
Batch formula
Description of manufacturing process and process controls
Controls of critical steps and intermediates
Process validation and/or evaluation
Electronic format guidance: NeeS
December 2010
3.2.S.4.4
3.2.S.4.5
3.2.S.5
3.2.S.6
3.2.S.7
3.2.S.7.1
3.2.S.7.2
3.2.S.7.3
3.2.S
3.2.S.1
3.2.S.1.1
3.2.S.1.2
3.2.S.1.3
3.2.S.2
3.2.S.2.1
3.2.S.2.2
3.2.S.2.3
3.2.S.2.4
3.2.S.2.5
3.2.S.2.6
3.2.S.3
3.2.S.3.1
3.2.S.3.2
3.2.S.4
3.2.S.4.1
3.2.S.4.2
3.2.S.4.3
.2.S.4.4
3.2.S.4.5
3.2.S.5
3.2.S.6
3.2.S.7
3.2.S.7.1
3.2.S.7.2
3.2.S.7.3
3.2.P
3.2.P.1
3.2.P.2
3.2.P.2.1
3.2.P.2.2
3.2.P.2.3
3.2.P.2.4
3.2.P.2.5
3.2.P.2.6
3.2.P.3
3.2.P.3.1
3.2.P.3.2
3.2.P.3.3
3.2.P.3.4
3.2.P.3.5
Page 18 of 33
Module 3
3.2.P.4
3.2.P.4.1
3.2.P.4.2
3.2.P.4.3
3.2.P.4.4
3.2.P.4.5
3.2.P.4.6
3.2.P.4
3.2.P.4.1
3.2.P.4.2
3.2.P.4.3
3.2.P.4.4
3.2.P.4.5
3.2.P.4.6
3.2.P.5
3.2.P.5.1
3.2.P.5.2
3.2.P.5.3
3.2.P.5.4
3.2.P.5.5
3.2.P.5.6
3.2.P.6
3.2.P.7
3.2.P.8
3.2.P.8.1
3.2.P.8.2
3.2.P.8.3
3.2.R
3.2.A
3.2.A.1
3.2.A.1
3.2.A.1
3.2.A.2
3.2.A.2
3.2.A.3
3.3
3.3
3.3
3.3
Quality
Control of excipient – compendial
Specifications
Analytical procedures
Validation of analytical procedures
Justification of specifications
Excipients of human or animal origin
Novel excipients
Control of excipient - non-compendial excipient
Specifications
Analytical procedures
Validation of analytical procedures
Justification of specifications
Excipients of human or animal origin
Novel excipients
Control of drug product
Specifications
Analytical procedures
Validation of analytical procedures
Batch analyses
Characterisation of impurities
Justification of specification(s)
Reference standards or materials
Container closure system
Stability
Stability summary and conclusions
Post-approval stability protocol and stability commitment
Stability data
Regional information
Appendices
Facilities and equipment – manufacturer
Facilities and equipment – manufacturer1
Facilities and equipment – manufacturer2
Adventitious agents safety evaluation – manufacturer
Adventitious agents safety evaluation – manufacturer1
Novel excipients
Literature references
Reference 1
Reference 2
Reference 3
3.2.P.4
3.2.P.4.1
Not Applicable
Not Applicable
Not Applicable
3.2.P.4.5
3.2.P.4.6
1 3.2.P.4
3.2.P.4.1
3.2.P.4.2
3.2.P.4.3
3.2.P.4.4
3.2.P.4.5
3.2.P.4.6
3.2.P.5
3.2.P.5.1
3.2.P.5.2
3.2.P.5.3
3.2.P.5.4
3.2.P.5.5
3.2.P.5.6
3.2.P.6
3.2.P.7
3.2.P.8
3.2.P.8.1
3.2.P.8.2
3.2.P.8.3
3.2.R
3.2.A
3.2.A.1
3.2.A.1
3.2.A.1
3.2.A.2
3.2.A.2
3.2.A.3
3.3
3.3
3.3
3.3
Module 4
4.2
4.2.1
4.2.1.1
Nonclinical study reports
Study reports
Pharmacology
Primary pharmacodynamics
study report 1
study report 2
study report 3
Secondary pharmacodynamics
study report 1
study report 2
study report 3
Safety pharmacology
study report 1
study report 2
study report 3
4.2
4.2.1
4.2.1.1
4.2.1.1
4.2.1.1
4.2.1.1
4.2.1.2
4.2.1.2
4.2.1.2
4.2.1.2
4.2.1.3
4.2.1.3
4.2.1.3
4.2.1.3
4.2.1.2
4.2.1.3
Electronic format guidance: NeeS
December 2010
Page 19 of 33
Module 4
4.2.1.4
4.2.2
4.2.2.1
4.2.2.2
4.2.2.3
4.2.2.4
4.2.2.5
4.2.2.6
4.2.2.7
4.2.3
4.2.3.1
4.2.3.2
4.2.3.3
4.2.3.3.1
4.2.3.3.2
4.2.3.4
4.2.3.4.1
4.2.3.4.2
Nonclinical study reports
Pharmacodynamic drug interaction
study report 1
study report 2
study report 3
Pharmacokinetics
Analytical methods and validation reports
study report 1
study report 2
study report 3
Absorption
study report 1
study report 2
study report 3
Distribution
study report 1
study report 2
study report 3
Metabolism
study report 1
study report 2
study report 3
Excretion
study report 1
study report 2
study report 3
Pharmacokinetic other pharmacokinetic studies drug
Iinteractions (nonclinical)
study report 1
study report 2
study report 3
Other pharmacokinetic studies
study report 1
study report 2
study report 3
Toxicology
Single-dose toxicity
study report 1
study report 2
study report 3
Repeat-dose toxicity
study report 1
study report 2
study report 3
Genotoxicity
In vitro
study report 1
In vivo
study report 1
study report 2
Carcinogenicity
Long-term studies
study report 1
Short- or medium term studies
study report 1
Electronic format guidance: NeeS
December 2010
4.2.1.4
4.2.1.4
4.2.1.4
4.2.1.4
4.2.2
4.2.2.1
4.2.2.1
4.2.2.1
4.2.2.1
4.2.2.2
4.2.2.2
4.2.2.2
4.2.2.2
4.2.2.3
4.2.2.3
4.2.2.3
4.2.2.3
4.2.2.4
4.2.2.4
4.2.2.4
4.2.2.4
4.2.2.5
4.2.2.5
4.2.2.5
4.2.2.5
4.2.2.6
4.2.2.6
4.2.2.6
4.2.2.6
4.2.2.7
4.2.2.7
4.2.2.7
4.2.2.7
4.2.3
4.2.3.1
4.2.3.1
4.2.3.1
4.2.3.1
4.2.3.2
4.2.3.2
4.2.3.2
4.2.3.2
4.2.3.3
4.2.3.3.1
4.2.3.3.1
4.2.3.3.2
4.2.3.3.2
4.2.3.3.2
4.2.3.4
4.2.3.4.1
4.2.3.4.1
4.2.3.4.2
4.2.3.4.2
Page 20 of 33
Module 4
4.2.3.4.3
4.2.3.5
4.2.3.5.1
4.2.3.5.2
4.2.3.5.3
4.2.3.5.4
4.2.3.6
4.2.3.7
4.2.3.7.1
4.2.3.7.2
4.2.3.7.3
4.2.3.7.4
4.2.3.7.5
4.2.3.7.6
4.2.3.7.7
4.3
Module 5
5.1
5.2
5.3
5.3.1
5.3.1.1
Nonclinical study reports
study report 2
Other studies
study report 1
study report 2
study report 3
Reproductive and developmental toxicity
Fertility and early embryonic development
study report 1
Embryo-foetal development
study report 1
study report 2
Prenatal and postnatal development, including maternal
function
study report 1
study report 2
study report 3
Studies in which the offspring (juvenile animals) are dosed
and/or further evaluated
study report 1
Local tolerance
study report 1
Other toxicity studies
Antigenicity
study report 1
study report 2
Immunotoxicity
study report 1
Mechanistic studies
study report 1
Dependence
study report 1
study report 2
Metabolites
study report 1
study report 2
study report 3
Impurities
study report 1
Other
study report 1
Literature references
Reference 1
Reference 2
Reference 3
Clinical study reports
Table of Contents
Tabular listing of all clinical studies
Clinical study reports
Reports of biopharmaceutic studies
Bioavailability (BA) study reports
study report 1
study report 2
Electronic format guidance: NeeS
December 2010
4.2.3.4.2
4.2.3.4.3
4.2.3.4.3
4.2.3.4.3
4.2.3.4.3
4.2.3.5
4.2.3.5.1
4.2.3.5.1
4.2.3.5.2
4.2.3.5.2
4.2.3.5.2
4.2.3.5.3
4.2.3.5.3
4.2.3.5.3
4.2.3.5.3
4.2.3.5.4
4.2.3.5.4
4.2.3.6
4.2.3.6
4.2.3.7
4.2.3.7.1
4.2.3.7.1
4.2.3.7.1
4.2.3.7.2
4.2.3.7.2
4.2.3.7.3
4.2.3.7.3
4.2.3.7.4
4.2.3.7.4
4.2.3.7.4
4.2.3.7.5
4.2.3.7.5
4.2.3.7.5
4.2.3.7.5
4.2.3.7.6
4.2.3.7.6
4.2.3.7.7
4.2.3.7.7
4.3
4.3
4.3
4.3
5.1
5.2
5.3
5.3.1
5.3.1.1
5.3.1.1
5.3.1.1
Page 21 of 33
Module 5
5.3.1.2
5.3.1.3
5.3.1.4
5.3.2
5.3.2.1
5.3.2.2
5.3.2.3
5.3.3
5.3.3.1
Clinical study reports
study report 3
Comparative BA and bioequivalence (BE) study reports
study report 1
study report 2
In vitro-in vivo correlation study reports
study 51002 – title page
study 51002 – synopsis
study 51002 – body
study 51002 – appendix-16-1-1
study 51002 – appendix-16-1-2
study 51002 – appendix-16-1-3
study 51002 – appendix-16-1-4
study 51002 – appendix-16-1-5
study 51002 – appendix-16-1-6
study 51002 – appendix-16-1-7
study 51002 – appendix-16-1-8
study 51002 – appendix-16-1-9
study 51002 – appendix-16-1-10
study 51002 – appendix-16-1-11
study 51002 – appendix-16-1-12
study 51002 – appendix-16-2-2
study 51002 – appendix-16-2-7
study 51002 – appendix-16-3-1
study 51002 – appendix-16-3-2
Reports of bioanalytical and analytical methods for human
studies
study 51003 – title-page.pdf
study 51003 – synopsis.pdf
study 51003 – body
study 51003 – appendix-16-1-1.pdf
study 51003 – appendix-16-1-2.pdf
study 51003 – appendix-16-1-3.pdf
study 51003 – appendix-16-1-4.pdf
study 51003 – appendix-16-1-5.pdf
study 51003 – appendix-16-1-7.pdf
study 51003 – appendix-16-1-8.pdf
study 51003 – appendix-16-1-9.pdf
study 51003 – appendix-16-1-10.pdf
study 51003 – appendix-16-1-11.pdf
study 51003 – appendix-16-1-12.pdf
study 51003 – appendix-16-2-2.pdf
study 51003 – appendix-16-2-7.pdf
study 51003 – appendix-16-3-1.pdf
study 51003 – appendix-16-3-2.pdf
Reports of studies pertinent to PK using human
biomaterials
Plasma protein binding study reports
study report 1
Reports of hepatic metabolism and drug interaction studies
study report 1
Reports of studies using other human biomaterials
study report 51006
Reports of human PK studies
Healthy subject PK and initial tolerability study reports
Electronic format guidance: NeeS
December 2010
5.3.1.1
5.3.1.2
5.3.1.2
5.3.1.2
5.3.1.3
5.3.1.3
5.3.1.3
5.3.1.3
5.3.1.3
5.3.1.3
5.3.1.3
5.3.1.3
5.3.1.3
5.3.1.3
5.3.1.3
5.3.1.3
5.3.1.3
5.3.1.3
5.3.1.3
5.3.1.3
5.3.1.3
5.3.1.3
5.3.1.3
5.3.1.3
5.3.1.4
5.3.1.4
5.3.1.4
5.3.1.4
5.3.1.4
5.3.1.4
5.3.1.4
5.3.1.4
5.3.1.4
5.3.1.4
5.3.1.4
5.3.1.4
5.3.1.4
5.3.1.4
5.3.1.4
5.3.1.4
5.3.1.4
5.3.1.4
5.3.1.4
5.3.2
5.3.2.1
5.3.2.1
5.3.2.2
5.3.2.2
5.3.2.3
5.3.2.3
5.3.3
5.3.3.1
Page 22 of 33
Module 5
5.3.3.2
5.3.3.3
5.3.3.4
5.3.3.5
5.3.4
5.3.4.1
5.3.4.2
5.3.5
5.3.5.1
5.3.5.2
5.3.5.3
5.3.5.4
5.3.6
5.3.7
Clinical study reports
study report 1
study report 2
Patient PK and initial tolerability study reports
study report 1
Intrinsic factor PK study reports
study report 1
Extrinsic factor PK study reports
study report 1
Population PK study reports
study report 1
Reports of human PD studies
Healthy subject PD and PK/PD study reports
study report 1
Patient PD and PK/PD study reports
study report 1
study report 2
Reports of efficacy and safety studies (confusion)
Study reports of controlled clinical studies pertinent to the
claimed indication
study ab12345 – synopsis
study ab12345 – report body
study ab12345 – protocol
study ab12345 – protocol amendment a
study ab12345 – randomisation code
study ab12345 – adverse events listings
study ab12345 – blank CRF
study ab12345 – demographic table
study ab12345 – ethics committee approval
study cd98765 – synopsis
study cd98765 – report body
study cd98765 – protocol
study cd98765 – randomisation code
study cd98765 – adverse events listings
study cd98765 – blank CRF
study cd98765 – demographic table
study cd98765 – ethics committee approval
Study reports of uncontrolled clinical studies
study report 51015
Reports of analyses of data from more than one study
study report 51016
Other clinical study reports
study report 51017
Post-marketing experience
Case report forms and individual patient listings when
submitted
study ab12345 – appendix 16-3-1
study ab12345 – appendix 16-3-2
study ab12345 – appendix 16-4
study cde98765 – appendix 16-3-1
study cde98765 – appendix 16-3-2
study cde98765 – appendix 16-4
study 51002 – appendix 16-3-1
study 51002 – appendix 16-3-2
study 51002 – appendix 16-4
Electronic format guidance: NeeS
December 2010
5.3.3.1
5.3.3.1
5.3.3.2
5.3.3.2
5.3.3.3
5.3.3.3
5.3.3.4
5.3.3.4
5.3.3.5
5.3.3.5
5.3.4
5.3.4.1
5.3.4.1
5.3.4.
5.3.4.2
5.3.4.2
5.3.5
5.3.5.1
5.3.5.1
5.3.5.1
5.3.5.1
5.3.5.1
5.3.5.1
5.3.5.1
5.3.5.1
5.3.5.1
5.3.5.1
5.3.5.1
5.3.5.1
5.3.5.1
5.3.5.1
5.3.5.1
5.3.5.1
5.3.5.1
5.3.5.1
5.3.5.2
5.3.5.2
5.3.5.3
5.3.5.3
5.3.5.4
5.3.5.4
Not Applicable
5.3.7
5.3.7
5.3.7
5.3.7
5.3.7
5.3.7
5.3.7
5.3.7
5.3.7
5.3.7
Page 23 of 33
Module 5
5.4
Clinical study reports
study 51003 – appendix 16-3-1
study 51003 – appendix 16-3-2
study 510023 – appendix 16-4
Literature references
Reference 1
Reference 2
Reference 3
Electronic format guidance: NeeS
December 2010
5.3.7
5.3.7
5.3.7
5.4
5.4
5.4
5.4
Page 24 of 33
Annex 3
Naming of files
Module 1 Administrative information and prescribing information for
Australia
The name of the folder for module 1 should be m1.
Section in
CTD
1.0
1.0.0
1.0.1
1.0.2
1.1
1.2
1.2.1
1.2.2
1.2.3
1.3
1.3.1
1.3.1.1
1.3.1.2
1.3.2
1.3.3
1.3.4
1.4
1.4.1
1.4.2
1.4.3
1.5
1.5.1
1.5.2
Description
Folder name
Letter of application
Electronic lodgement cover sheet
Letter of application
Responses to questions
Comprehensive table of contents
Application forms
Application form
Pre-submission details
Patent certification
Medicine information documents, packaging, and labelling
Proposed Australian product information and package insert
Proposed Australian product information and package insert
Proposed Australian product information and package insert - annotated
Proposed Australian consumer medicine information
Therapeutic goods and use of human embryos or human embryonic stem cells
or material derived from them
Label mock-ups and specimens
Information about the experts
Information about the expert - Quality
Information about the expert – Non-clinical
Information about the expert - Clinical
Specific requirements for different types of applications
Literature based submission documents
Orphan drug designation
m1-0-letter-applic
m1-0-0-elect-lodge
m1-0-1-letter-applic
m1-0-2-responses-quest
m1-1-toc
m1-2-applic-form
m1-2-1-applic-form
m1-2-2-pre-submission
m1-2-3-patent-certification
m1-3-aust-labelling-packaging
m1-3-1-proposed–pi
m1-3-1-1-proposed–pi
m1-3-1-2-annotated-proposed–pi
m1-3-1-proposed–cmi
m1-3-3-embryo-declaration
Electronic format guidance: NeeS
December 2010
Page 25 of 33
m1-3-4-label-mock-up
m1-4-expert
m1-4-1-quality
m1-4-2-non-clinical
m1-4-3-clinical
m1-5-specific-requirements
m1-5-1-literature-based
m1-5-2-orphan
1.5.3
1.10.2.1
1.10.2.2
1.10.2.3
1.10.2.4
1.10.3
1.11
1.11.1
1.11.2
Genetically modified organisms: Consent from the Office of the Gene
Technology Regulator
Additional trade name declarations
Co-marketed medicine declarations
Drug and plasma master files and Certificates of Suitability of Monographs of the
European Pharmacopoeia
Relevant external sources
Sponsor’s declaration
Letters of access
Certificates of suitability (including Annexes)
Good manufacturing practice
List of Australian manufacturer names and licence numbers
GMP clearance letters for all overseas manufacturing sites
Copies of applications for TGA GMP clearances
Compliance with meetings and pre-submission processes
Details of compliance with pre-submission meeting outcomes
Details of any additional data to be submitted
Declaration of compliance with pre-submission planning form and planning letter
Individual patient data
Individual patient data
Overseas regulatory status
Overseas regulatory status
Product information from Canada, the Netherlands, New Zealand, Sweden, UK
and USA
US prescribing information
EU summary of product characteristics
Canadian product monograph
NZ data sheet
Data set similarities and differences
Summary of biopharmaceutic studies
Summary of a bioavailability or bioequivalence study
Justification for not providing appropriate biopharmaceutic studies
1.12
1.12.1
1.13
Paediatric development program
References to paediatric development program
Information relating to pharmacovigilance
1.5.4
1.5.5
1.6
1.6.1
1.6.2
1.6.3
1.6.4
1.7
1.7.1
1.7.2
1.7.3
1.8
1.8.1
1.8.2
1.8.3
1.9
1.9.1
1.10
1.10.1
1.10.2
Electronic format guidance: NeeS
December 2010
m1-5-3-gmo-consents
m1-5-4-attitional-trad-name
m1-5-5-co-marketed-medicine
m1-6-drug-master-files-cert-ofsuitability
m1-6-1-dmf-pms-cosm1-6-2-sponsors declaration
m1-6-3-letters of access
m1-6-4-cert-of-suitability
m1-7-good-manufacturing-pactice
m1-7-1-aust-mfrs
m1-7-2-os-mfrs
m1-7-3-os-mfrs-without-clearance
m1-8-meetings
m1-8-1-compliance-pre-sub-meeting
m1-8-2-additional data-details
m1-8-3-compliance-pre-sub-form
m1-9-indiv-patient-data
m1-9-1-indiv-patient-data
m1-10-overseas-reg-status
m1-10-1-overseas-reg-status
m1-10-2-other-countries-pi
m1-10-2-1-us
m1-10-2-2-eu
m1-10-2-3-canada
m1-10-2-4-new-zealand
m1-10-3-dataset-similarities
m1-11-summary-biopharm-studies
m1-11-1-summary-biopharm-studies
m1-11-2-justification- no-biopharmstudies
m1-12-paediatrics
m1-13-pharmacovigilance
Page 26 of 33
1.13.1
Annex I
Annex II
Risk management plan for Australia
Antibiotic resistance data
Overseas evaluation reports
m1-13-1-riskmgt-system
m1-annex1-antibiotic-resist
m1-annex2-other-countriesevaluation-report
Module 2 Summaries
The name of the folder for module 2 should be m2.
Section in
CTD
2.1
2.2
2.3
2.4
2.5
2.6
2.7
Description
Folder name
Table of contents
Introduction
Quality overall summary
Nonclinical overview
Clinical overview
Nonclinical written and tabulated summaries
Clinical summary
21-toc
22-intro
23-qos
24-nonclin-over
25-clin-over
26-nonclin-sum
27-clin-sum
Module 3 Quality
The name of the folder for module 3 should be m3.
Section in
CTD
3.1
3.2
3.2.S
3.2.S
3.2.S.1
3.2.S.2
Description
Folder name
Table of contents
Body of data
Drug substance
Drug substance [name] [manufacturer]
General information (name, manufacturer1)
Manufacture (name, manufacturer1)
31-toc
32-body-data
32s-drug-sub
substance-1-manufacturer-1
32s1-gen-info
32s2-manuf
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December 2010
Page 27 of 33
3.2.S.3
3.2.S.4
3.2.S.4.1
3.2.S.4.2
3.2.S.4.3
3.2.S.4.4
3.2.S.4.5
3.2.S.5
3.2.S.6
3.2.S.7
3.2.P
3.2.P
3.2.P.1
3.2.P.2
3.2.P.3
3.2.P.4
3.2.P.4
3.2.P.5
3.2.P.5.1
3.2.P.5.2
3.2.P.5.3
3.2.P.5.4
3.2.P.5.5
3.2.P.5.6
3.2.P.6
3.2.P.7
3.2.P.8
3.2.A
3.2.A.1
3.2.A.2
3.2.A.3
3.2.R
Characterisation (name, manufacturer1)
Control of drug substance (name, manufacturer1)
Specification (name, manufacturer1)
Analytical procedures (name, manufacturer1)
Validation of analytical procedures (name, manufacturer1)
Batch analyses (name, manufacturer1)
Justification of specification (name, manufacturer1)
Reference standards or materials (name, manufacturer1)
Container closure system (name, manufacturer1)
Stability (name, manufacturer1)
Drug product (name, dosage form)3
Drug product (name, dosage form) – name
Description and composition of the drug product (name, dosage form)
Pharmaceutical development (name, dosage form)
Manufacture (name, dosage form)
Control of excipients (name, dosage form)
Control of excipients (name, dosage form) – Excipient 1
Control of drug product (name, dosage form)
Specification(s) (name, dosage form)
Analytical procedures (name, dosage form)
Validation of analytical procedures (name, dosage form)
Batch analyses (name, dosage form)
Characterisation of impurities (name, dosage form)
Justification of specifications (name, dosage form)
Reference standards or materials (name, dosage form)
Container closure system (name, dosage form)
Stability (name, dosage form)
Appendices
Facilities and equipment (name, manufacturer1)
Adventitious agents safety evaluation (name, dosage form, manufacturer1)
Excipients- Name4
Regional information5
Electronic format guidance: NeeS
December 2010
Page 28 of 33
32s3-charac
32s4-contr-drug-sub
32s41-spec
32s42- analyt-proc
32s43-val-analyt-proc
32s44-batch-analys
32s45-justif-spec
32s5-ref-stand
32s6-cont-closure-sys
32s7-stab
32p-drug-prod
product-1
32p1-desc-comp
32p2-pharm-dev
32p3-manuf
32p4-contr-excip
excipient-1
32p5-contr-drug-prod
32p51-spec
32p52-analyt-proc
32p53-val-analyt-proc
32p54-batch-analys
32p55-charac-imp
32p56-justif-spec
32p6-ref-stand
32p7-cont-closure-sys
32p8-stab
32a-app
32a1-fac-equip
32a2-advent-agent
32a3-excip-name-1
32r-reg-info
3.3
Literature references
33-lit-ref
Module 4 Nonclinical Study Reports
The name of the folder for module 4 should be m4.
Section in
CTD
4.1
4.2
4.2.1
4.2.1.1
4.2.1.2
4.2.1.3
4.2.1.4
4.2.2
4.2.2.1
4.2.2.2
4.2.2.3
4.2.2.4
4.2.2.5
4.2.2.6
4.2.2.7
4.2.3
4.2.3.1
4.2.3.2
4.2.3.3
4.2.3.3.1
4.2.3.3.2
4.2.3.4
4.2.3.4.1
Description
Folder name
Table of contents
Study reports
Pharmacology
Primary pharmacodynamics
Secondary pharmacodynamics
Safety pharmacology
Pharmacodynamic drug interactions
Pharmacokinetics
Analytical methods and validation reports (if separate reports are available)
Absorption
Distribution
Metabolism
Excretion
Pharmacokinetic drug interactions (nonclinical)
Other pharmacokinetic studies
Toxicology
Single-dose toxicity (in order by species, by route)
Repeat-dose toxicity (in order by species, by route, by duration, including
supportive toxicokinetics evaluations)
Genotoxicity
In vitro
In vivo (including supportive toxicokinetics evaluations)
Carcinogenicity (including supportive toxicokinetics evaluations)
Long-term studies (in order by species, including range-finding studies that
41-toc
42-stud-rep
421-pharmacol
4211-prim-pd
4212-sec-pd
4213-safety-pharmacol
4214-pd-drug-interact
422-pk
4221-analyt-met-val
4222-absorp
4223-distrib
4224-metab
4225-excr
4226-pk-drug-interact
4227-other-pk-stud
423-tox
4231-single-dose-tox
Electronic format guidance: NeeS
December 2010
Page 29 of 33
4232-repeat-dose-tox
4233-genotox
42331-in-vitro
42332-in-vivo
4234-carcigen
42341-lt-stud
4.2.3.4.2
4.2.3.4.3
4.2.3.5
4.2.3.5.1
4.2.3.5.2
4.2.3.5.3
4.2.3.5.4
4.2.3.6
4.2.3.7
4.2.3.7.1
4.2.3.7.2
4.2.3.7.3
4.2.3.7.4
4.2.3.7.5
4.2.3.7.6
4.2.3.7.7
4.3
cannot be appropriately included under repeat-dose toxicity or pharmacokinetics)
Short-or medium-term studies (including range-finding studies that cannot be
appropriately included under repeat-dose toxicity or pharmacokinetics)
Other studies
Reproductive and developmental toxicity (including range-finding studies and
supportive toxicokinetics evaluations)
Fertility and early embryonic development
Embryo-foetal development
Prenatal and postnatal development, including maternal function
Studies in which the offspring (juvenile animals) are dosed and/or further
evaluated
Local tolerance
Other toxicity studies (if available)
Antigenicity
Immunotoxicity
Mechanistic studies (if not included elsewhere)
Dependence
Metabolites
Impurities
Other
Literature references
42342-smt-stud
42343-other-stud
4235-repro-dev-tox
42351-fert-embryo-dev
42352-embryo-fetal-dev
42353-pre-postnatal-dev
42354-juv
4236-loc-tol
4237-other-tox-stud
42371-antigen
42372-immunotox
42373-mechan-stud
42374-dep
42375-metab
42376-imp
42377-other
43-lit-ref
Module 5 Clinical Study Reports
The name of the folder for module 5 should be m5.
Section in
CTD
5.1
5.2
5.3
5.3.1
Description
Folder name
Table of contents
Tabular listing of all clinical studies
Clinical study reports
Reports of biopharmaceutic studies
51-toc
52-tab-list
53-clin-stud-rep
531-rep-biopharm-stud
Electronic format guidance: NeeS
December 2010
Page 30 of 33
5.3.1.1
5.3.1.2
5.3.1.3
5.3.1.4
5.3.2
5.3.2.1
5.3.2.2
5.3.2.3
5.3.3
5.3.3.1
Bioavailability (BA) study reports
"Study report 1"
"Study report 2"
"Study report 3"
Comparative BA and bioequivalence (BE) study reports
"Study report 1"
"Study report 2"
"Study report 3"
In vitro – In vivo correlation study reports
"Study report 1"
"Study report 2"
"Study report 3"
Reports of bioanalytical and analytical methods for human studies
"Study report 1"
"Study report 2"
"Study report 3"
Reports of studies pertinent to pharmacokinetics using human biomaterials
Plasma protein binding study reports
"Study report 1"
"Study report 2"
"Study report 3"
Reports of hepatic metabolism and drug interaction studies
"Study report 1"
"Study report 2"
"Study report 3"
Reports of studies using other human biomaterials
"Study report 1"
"Study report 2"
"Study report 3"
Reports of human pharmacokinetic (PK) studies
Healthy subject PK and initial tolerability study reports
"Study report 1"
Electronic format guidance: NeeS
December 2010
Page 31 of 33
5311-ba-stud-rep
study-report-1
study-report-2
study-report-3
5312-compar-ba-be-stud-rep
study-report-1
study-report-2
study-report-3
5313-in-vitro-in-vivo-corr-stud-rep
study-report-1
study-report-2
study-report-3
5314-bioanalyt-analyt-met
study-report-1
study-report-2
study-report-3
532-rep-stud-pk-human-biomat
5321-plasma-prot-bind-stud-rep
study-report-1
study-report-2
study-report-3
5322-rep-hep-metab-interact-stud
study-report-1
study-report-2
study-report-3
5323-stud-other-human-biomat
study-report-1
study-report-2
study-report-3
533-rep-human-pk-stud
5331-healthy-subj-pk-init-tol-stud-rep
study-report-1
5.3.3.2
5.3.3.3
5.3.3.4
5.3.3.5
5.3.4
5.3.4.1
5.3.4.2
5.3.5
5.3.5
5.3.5.1
"Study report 2"
"Study report 3"
Patient PK and initial tolerability study reports
"Study report 1"
"Study report 2"
"Study report 3"
Intrinsic factor PK study reports
"Study report 1"
"Study report 2"
"Study report 3"
Extrinsic factor PK study reports
"Study report 1"
"Study report 2"
"Study report 3"
Population PK study reports
"Study report 1"
"Study report 2"
"Study report 3"
Reports of human Pharmacodynamic (PD) studies
Healthy subject PD and PK/PD study reports
"Study report 1"
"Study report 2"
"Study report 3"
Patient PD and PK/PD study reports
"Study report 1"
"Study report 2"
"Study report 3"
Reports of efficacy and safety studies
Reports of efficacy and safety studies – indication name
Study reports of controlled clinical studies pertinent to the claimed indication
"Study report 1"
"Study report 2"
Electronic format guidance: NeeS
December 2010
Page 32 of 33
study-report-2
study-report-3
5332-patient-pk-init-tol-stud-rep
study-report-1
study-report-2
study-report-3
5333-intrin-factor-pk-stud-rep
study-report-1
study-report-2
study-report-3
5334-extrin-factor-pk-stud-rep
study-report-1
study-report-2
study-report-3
5335-popul-pk-stud-rep
study-report-1
study-report-2
study-report-3
534-rep-human-pd-stud
5341-healthy-subj-pd-stud-rep
study-report-1
study-report-2
study-report-3
5342-patient-pd-stud-rep
study-report-1
study-report-2
study-report-3
535-rep-effic-safety-stud
indication-1
5351-stud-rep-contr
study-report-1
study-report-2
5.3.5.2
5.3.5.3
5.3.5.4
5.3.6
5.3.7
5.4
"Study report 3"
Study reports of uncontrolled clinical studies
"Study report 1"
"Study report 2"
"Study report 3"
Reports of analyses of data from more than one study
"Study report 1"
"Study report 2"
"Study report 3"
Other study reports
"Study report 1"
"Study report 2"
"Study report 3"
Reports of postmarketing experience
Case report forms and individual patient listings6
“Study report 1”
“Study report 2”
“Study report 3”
Literature references
Electronic format guidance: NeeS
December 2010
study-report-3
5352-stud-rep-uncontr
study-report-1
study-report-2
study-report-3
5353-rep-analys-data-more-one-stud
study-report-1
study-report-2
study-report-3
5354-other-stud-rep
study-report-1
study-report-2
study-report-3
536-postmark-exp
537-crf-ipl
study-report-1
study-report-2
study-report-3
54-lit-ref
Page 33 of 33